Zosano Pharma Completes Enrollment in Phase 1 Study for Microneedle Patch Delivery of Zolmitriptan for the Treatment of Migraine

Published on September 1, 2015

FREMONT, Calif., Sept. 1, 2015 (GLOBE NEWSWIRE) — Zosano Pharma Corporation (NASDAQ: ZSAN), a clinical-stage specialty pharmaceutical company that has developed a proprietary transdermal microneedle patch system to deliver therapeutics conveniently through the skin for the treatment of a variety of indications, announced today that it has completed enrollment in a Phase 1 clinical study for a novel method for delivering treatments for migraine headaches.

The crossover study among 20 healthy volunteers will test the tolerability and pharmacokinetics of up to five doses of ZP-Triptan compared to subcutaneous injection of sumatriptan and oral administration of zolmitriptan. ZP-Triptan is a zolmitriptan-coated microneedle patch that is applied to an individual’s upper arm to deliver zolmitriptan to the body. ZP-Triptan has the potential to demonstrate rapid onset comparable to subcutaneous administration with the injection-free and ease-of-use characteristics of Zosano’s microneedle patch and applicator system.

“The ZP-Triptan program is an important component of Zosano’s clinical portfolio,” said Zosano’s Chief Medical Officer Thorsten von Stein, M.D., Ph.D. “We’ve reached a critical milestone with the completion of enrollment in the Phase 1 clinical study. We anticipate having data by the end of 2015.”

During Part 1 of the study, the 20 participants will be randomized and receive the following treatments: a 0.48 mg ZP-Triptan patch, two 0.48 mg ZP-Triptan patches, a 1.9 mg ZP-Triptan patch, a 2.5 mg oral zolmitriptan tablet, and a subcutaneous injection of sumatriptan, a common treatment for migraine headaches. Part 2 and Part 3 of the study will be higher dose tolerability studies, testing two 1.9 mg ZP-Triptan patches and a 3.8 mg ZP-Triptan patch. The study is designed to examine time to onset, bioavailability and safety and tolerability for the microneedle patch doses compared to commercially available products.

About Zosano Pharma

Zosano Pharma Corporation is a clinical-stage specialty pharmaceutical company that has developed a proprietary transdermal microneedle patch system to deliver drug formulations through the skin for the treatment of a variety of indications. Zosano Pharma’s microneedle patch system offers rapid onset, consistent drug delivery, improved ease of use and room-temperature stability, benefits that the company believes often are unavailable using oral formulations or injections. Zosano Pharma’s microneedle patch system has the potential to deliver numerous medications for a wide variety of indications in commercially attractive markets. It has been tested in more than 400 patients with over 30,000 patches successfully applied to humans in Phase 1 and Phase 2 clinical studies. Learn more at www.zosanopharma.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding expected clinical activities and other future events. Readers are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” “unaudited,” “approximately” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading “Risk Factors” in Zosano Pharma Corporation’s Annual Report on Form 10-K for the year ended December 31, 2014 filed with Securities and Exchange Commission on March 26, 2015. Although the company believes that the expectations reflected in these forward-looking statements are reasonable, it cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano Pharma and Zosano Pharma assumes no obligation to update any such forward-looking statements.